Cancer Exercise: Evaluation of a Mobile App in Breast Cancer Survivors

NCT06791018 | Active Not Recruiting DMC

• 1 other identifier: HREBA.CC-24-0455
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine whether a mobile app increases exercise levels in breast cancer survivors after treatments, reduces fatigue, and improves physical functions. This experimental study has 200 participants placed into one of two groups. One group will be asked to use the cancer-specific exercise app over 12 weeks, and the other group will receive the cancer exercise guidelines. Exercise will be measured by self-report questionnaires before and after the intervention and three months later. Self-report questionnaires will measure fatigue and quality of life. This research will determine whether a simple mobile app helps increase exercise in breast cancer survivors. Mobile apps to increase exercise may be provided to all breast cancer survivors after treatments to help them recover and possibly improve survival.

Conditions

Breast Cancer; Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Keywords

Breast neoplasm; Digital technology; Mobile app; Exercise; Behavior

Outcome Measures

Primary Outcomes (1)

• Exercise Level

  An increase in time in moderate to vigorous exercise levels in minutes per week is the primary endpoint of this study. The efficacy of the app intervention will be assessed by the modified Leisure Score Index from the Godin Leisure-Time Exercise Questionnaire. Participants will be asked to recall their average weekly frequency and duration of light, moderate, and vigorous exercise during the past month that lasted at least 10 minutes and was done during free time. Exercise minutes/week will be calculated for moderate and vigorous exercise. Total exercise minutes will be calculated by adding aerobic minutes and strength minutes.

  At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.

Secondary Outcomes (8)

• Health-related quality of life (HRQoL)

  At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.

• Cancer-Related Fatigue

  At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.

• Upper Limb Function

  At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.

• Exercise behavior

  At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.

• Capability for Exercise

  At baseline (enrollment), 12 weeks (post-intervention), and 3-month follow-up.

Other Outcomes (5)

• Number of App Logins Per Week

  From enrollment to up to 12 weeks.

• Time Spent on the App (Minutes Per Week)

  From enrollment to up to 12 weeks.

• Session Intervals on the App

  From enrollment to up to 12 weeks.

Study Arms (2)

Cancer-specific exercise app

EXPERIMENTAL

Participants randomized in this group will be asked to use the app for 12 weeks. Participants will be ask to preferably spread each exercise session over different days of the week. While exercise equipment is not required, the app includes options for using elastic resistance bands or dumbbells. Following baseline assessment and randomization, participants in the intervention group will receive a brief instructional video on how to download and use the app, along with access to a website offering support materials, guidelines, and additional instructional videos. All participants will complete questionnaires at baseline, 12 weeks (post-intervention), and 3 months follow-up.

Other: Exercise

Usual care

NO INTERVENTION

This group will received the ACSM exercise guidelines.

Interventions

Exercise OTHER

Participants will be asked to use a cancer-specific exercise mobile app for 12 weeks. The program is designed to achieve the goal of exercising for at least 90 minutes per week, including aerobic exercise three times a week and resistance training twice a week. While exercise equipment is not required, the app supports the optional use of an elastic resistance band or a pair of dumbbells. The app comes with various features to support the exercise journey. Participants will be able to track their progress through periodic testing, access a library of resources that includes information on exercise, and log any additional workouts they perform outside the app. The exercise prescription will be tailored to daily fatigue levels that will be rated before each workout. This ensures that the program is customized to meet individual needs and abilities.

Also known as: Cancer-specific exercise app

Cancer-specific exercise app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age, diagnosed with histologically confirmed stage I, II, or III breast cancer, \> 1 to 5 years after diagnosis (2020-2024) and completed all treatments except hormone therapy, own a smartphone (Apple or Android), able to read and understand English, and interested in increasing exercise.

You may not qualify if:

• Not being medically cleared to participate in the exercise intervention by a certified exercise physiologist using the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) (e.g., known cardiac disease or uncontrolled hypertension), evidence of cancer recurrence, stage IV metastatic breast cancer and unable to walk without material or physical support.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Exercise Oncology Research Laboratory, Faculty of Kinesiology, Sport and Recreation, University of Alberta.

Edmonton, Alberta, T6G 2H9, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and investigators will not be blinded to group assignment given the nature of the intervention.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention is a cancer-specific mobile application with the aim of increasing exercise levels in cancer survivors.

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 24, 2025
• Study Start: May 23, 2025
• Primary Completion: December 20, 2025
• Study Completion (Estimated): May 20, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)